Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke

First Affiliated Hospital of Wannan Medical College

Status: Completed

Conditions: Stroke; Time Restricted Feeding

Treatments: Other: Time-restricted enteral nutrition therapy group; Other: Continuous enteral nutrition control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06161948

2023AH040243

Details and patient eligibility

About

In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.

Full description

Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.

On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.

The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.

On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.

Enrollment: 420 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old and <80 years old;
• Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset;
• GCS score ≤12 points or NIHSS score ≥11 points on admission,
• Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days;
• Signed informed consent form.

Exclusion criteria

• Complete parenteral nutrition is required due to contraindications to enteral nutrition;
• After gastrectomy or intestinal resection;
• Enteral nutrition treatment has been performed for >12 hours;
• Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency [ejection fraction ≤ 50%]; c. Severe liver failure [Child Pugh score ≥ 7]; d. Severe renal failure [glomerular filtration] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL])
• Have a history of mental illness or mRS ≥ 3 points;
• The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient;
• During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of <90 days;
• The patient participates in another clinical study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Time-restricted group

Experimental group

Description:

Time-restricted enteral nutrition therapy group

Treatment:

Other: Time-restricted enteral nutrition therapy group

Continuous group

Other group

Description:

Continuous enteral nutrition control group

Treatment:

Other: Continuous enteral nutrition control group